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New toothpaste containing an anti-microbial agent to combat tooth decay during orthodontic treatment

Synthesis of a novel dentifrice containing 4-HCA and assessing its effect in preventing white spot lesions in patients undergoing orthodontic treatment - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074319
Enrollment
90
Registered
2024-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: 0.2% 4-HCA: 0.2% w/w of 4-hydroxycinnamic acid in the dentifrice. Pea sized amount of dentifrice to be used while brushing every day twice (once in the morning and once at night) for 3

Sponsors

Manjiri Bhate
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing orthodontic treatment with fixed appliance

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
White spot lesions assessment using- Photographic analysis of teeth ICDAS scoring DIAGNOdent Periodontal outcomes- Plaque index Bacterial counts using Real-time Polymerase Chain Reaction (RT-PCR)Timepoint: Baseline and at 6 months

Secondary

MeasureTime frame
Periodontal outcomes- Plaque index Bacterial counts using Real-time Polymerase Chain Reaction (RT-PCR)Timepoint: Baseline and 6 momths

Countries

India

Contacts

Public ContactRavindra Kumar Jain

Saveetha Dental College and Hospital

ravindrakumar@saveetha.com9884729660

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026